A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.

Study Overview

• Status: Completed
• Conditions: B Cell Lymphoma
• Intervention / Treatment: Biological: CD20-directed CAR-T cells with CliniMACS Prodigy® system

Detailed Description

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200065
    • Shanghai Tongji Hospital, Tongji University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient volunteered to participate in the study, and signed the Informed Consent
2. Age 18-70 years old, male or female
3. Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
4. r/r lymphoma patients who received prior CD19 CAR-T therapy
5. At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
6. No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
7. No mAb treatment within 2 weeks before C-CAR066 infusion
8. Adequate organ and bone marrow function
9. No contraindications of apheresis
10. Expected survival time > 3 months
11. ECOG scores 0-1

Exclusion Criteria:

1. Have a history of allergy to cellular products
2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
4. Patients with active CNS involvement
5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
7. Live vaccination within 4 weeks before apheresis
8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
9. Have a history of alcoholism, drug addiction and mental illness
10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
11. Patients with severe fludarabine or cyclophosphamide hypersensitivity

12. The patient has a history of other primary cancers, except for the following:

    1. Non-melanoma such as skin basal cell carcinoma cured by resection
    2. Cured carcinoma in situ such as cervical, bladder or breast cancer
13. The investigators believe that there are other circumstances that are not suitable for the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-CAR066; Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion	Biological: CD20-directed CAR-T cells with CliniMACS Prodigy® system; Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously; Other Names: C-CAR066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	The incidence of treatment-emergent adverse events (TEAEs)	Up to 12 weeks after C-CAR066 infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The percentage of subjects who achieved complete response and partial response	Up to 24 months after C-CAR066 infusion
Complete response rate (CRR)	The percentage of subjects who achieved complete response	Up to 24 months after C-CAR066 infusion
Duration of response (DOR)	The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR066 infusion	Up to 24 months after C-CAR066 infusion
Progression free survival (PFS)	The time from C-CAR066 infusion to the date of progression as assessed by Lugano 2014 criteria or death	Up to 24 months after C-CAR066 infusion
Overall survival (OS)	Time from C-CAR066 infusion to death from any cause	Up to 24 months after C-CAR066 infusion

Collaborators and Investigators

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
• Collaborators: Shanghai AbelZeta Ltd.
• Investigators: Principal Investigator: Aibin Liang, MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: B cell lymphoma received prior CD19 CAR-T therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: 0504-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No